BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 5 ML SYRINGE

    MDR report key: 9935967 · Received April 8, 2020

    Report

    Report Number
    2243072-2020-00568
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 18, 2020
    Report Date
    March 20, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW TWO PHOTOS OF DISCARDIT 5 ML FROM LOT # 9143706, REGARDING ITEM # 300847 WITH THE REPORTED ISSUE OF ¿DISCARIDT SYRINGES 5ML WAS NOT PROPERLY PACKED AND ORDINARY PAPER WAS USED IN PACKING INSTEAD OF MEDICAL GRADE PAPER¿. DHR REVIEWED FOUND NO NON-CONFORMITIES. TWO PHOTOGRAPHS RECEIVED FROM THE CUSTOMER. THE INVESTIGATING TEAM DID NOT RECEIVE ANY CUSTOMER RETURN SAMPLES. BD TEAM HAS RECEIVED TWO PHOTOGRAPHS AND THE TEAM HAS INVESTIGATED THE PHOTOGRAPHS AND THE RETENTION SAMPLES OF MATERIAL NUMBER 300847 FOR LOT NUMBER 9143706. THE TEAM DID NOT FIND ANY DEFECT IN THE RETENTION SAMPLES OF 9143706. THE DEFECT COULD NOT BE CONFIRMED ON THE PHOTOGRAPHS RECEIVED. REQUESTING THE CUSTOMER RETURN SAMPLE TO INVESTIGATE THE COMPLAINT AND TAKE A CORRECTIVE AND PREVENTIVE ACTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MATERIAL USED IN PACKING OF DEVICE WAS COMPROMISED THUS AFFECTING STERILITY WITH A BD DISCARDIT¿ II 5 ML SYRINGE. THIS OCCURRED ON 20 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCARIDT SYRINGES 5ML WAS NOT PROPERLY PACKED AND ORDINARY PAPER WAS USED IN PACKING INSTEAD OF MEDICAL GRADE PAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400263 BD DISCARDIT II 5 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 9143706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other